MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV 4F DL FULL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refp1117 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that picc required replacement due to internal kinks.No other information was provided.
Event or Problem Description
It was reported that picc required replacement due to internal kinks.No other information was provided.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of catheter kinking is confirmed but the exact cause remains unknown.One 4 fr dl powerpicc catheter was returned for evaluation.Blood residue and evidence of use was visible throughout the catheter surface.The catheter extended up to the 47 cm depth marker.Two kinks were noted at the 9 cm and 18 cm depth marker.The catheter was cut near the 11 cm depth marker in order to inspect the catheter wall and lumen thickness.The dimensional properties were found to be within manufacturing specification.Based on the condition of the returned sample, possible contributing factors include advancement against resistance, placement location, and manipulation of the catheter during use.Since a kink was observed to be present in the catheter, the complaint is confirmed but the exact causing factors and conditions remain unknown.H3 other text : evaluation findings are in section h.11.

• Brand Name: DOT PROV 4F DL FULL 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12351410
• Report Number: 3006260740-2021-03442
• Device Sequence Number: 14383249
• Product Code: LJS
• UDI-Device Identifier: 00801741130120
• UDI-Public: (01)00801741130120
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: S1274108
• Device Lot Number: REFP1117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR
• Patient Weight: 53